What changed in this filing

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Item 1. Financial Statements

2026-05-07 compared with 2025-11-13 · 149 added, 289 removed, 340 unchanged (56% of the section changed)

3 unchanged sentences

(Amounts in thousands, except share and per share data)

September 30,

Current assets:

3 unchanged sentences

Total current assets

17,402 21,476

Property and equipment, net

8 unchanged sentences

Series D Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized;

0 issued and outstanding at each of September 30, 2025 and December 31, 2024

0 issued and outstanding at each of March 31, 2026 and December 31, 2025

Common stock, $ 0.0001 par value, 100,000,000 shares authorized;

5,784,770 and 1,733,717 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

11,617,250 and 11,617,250 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital

3 unchanged sentences

Total stockholders' equity

$ 16,462 $ 20,147

Total liabilities and stockholders' equity

5 unchanged sentences

Three Months Ended

Nine Months Ended

September 30,

Operating expenses:

Research and development

$ 2,793 $ 886

General and administrative

1 unchanged sentence

Operating loss

Interest income (expense), net

( 4,167 ) ( 1,872 )

Interest income, net

Other income (expense), net

$ ( 4,003 ) $ ( 1,769 )

Net loss per common share:

Basic and diluted

( 0.34 ) ( 0.41 )

Weighted average number of common shares outstanding

Basic and diluted

11,617,250 4,307,264

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands, except share data)

For the Three and Nine Months Ended September 30, 2025

For the Three Months Ended March 31, 2026

Balance at December 31, 2025

11,617,250 $ 1 $ 175,200 $ ( 155,054 ) $ 20,147

Issuance of common stock upon exercise of warrants

537,432 - 2,680 - 2,680

Issuance of common stock and warrants, net of offering costs of $ 1,028

2,507,005 - 6,493 - 6,493

Stock-based compensation expense

- - 318 - 318

Balance at March 31, 2025

- - - ( 4,003 ) ( 4,003 )

Stock-based compensation expense

Issuance of common stock upon exercise of warrants

20,000 - 40 - 40

- - - ( 2,166 ) ( 2,166 )

Balance at June 30, 2025

4,798,154 $ - $ 160,386 $ ( 150,291 ) $ 10,095

Issuance of common stock upon exercise of warrants

100,000 - 200 - 200

Issuance of common stock and warrants, net of offering costs of $ 435

828,596 1 1,852 - 1,853

Issuance of common stock upon vesting of restricted stock units

71,000 - - - -

Shares withheld for payroll taxes

( 12,980 ) - ( 30 ) - ( 30 )

Stock-based compensation expense

- - 113 - 113

- - - ( 2,392 ) ( 2,392 )

Balance at September 30, 2025

Balance at March 31, 2026

11,617,250 $ 1 $ 175,518 $ ( 159,057 ) $ 16,462

For the Three and Nine Months Ended September 30, 2024

For the Three Months Ended March 31, 2025

Balance at December 31, 2024

2 unchanged sentences

537,432 - 2,680 - 2,680

Issuance of common stock upon vesting of restricted stock units

2,689 - - - -

Shares withheld for payroll taxes

( 689 ) - ( 4 ) - ( 4 )

Stock-based compensation expense

- - - ( 2,154 ) ( 2,154 )

Balance at March 31, 2024

510,188 $ - $ 146,964 $ ( 141,360 ) $ 5,604

Stock-based compensation expense

- - - ( 1,846 ) ( 1,846 )

Balance at June 30, 2024

510,188 $ - $ 146,979 $ ( 143,206 ) $ 3,773

Cash-in-lieu of fractional shares for reverse stock split

( 255 ) - ( 1 ) - ( 1 )

Issuance of common stock and warrants, net of offering costs

2,507,005 - 6,493 - 6,493

Issuance of common stock upon exercise of warrants

231,758 - - - -

Stock-based compensation expense

- - - ( 1,769 ) ( 1,769 )

Balance at September 30, 2024

Balance at March 31, 2025

4,778,154 $ - $ 160,295 $ ( 148,125 ) $ 12,170

3 unchanged sentences

(Amounts in thousands)

Nine Months Ended

September 30,

Three Months Ended

Cash flows from operating activities:

$ ( 4,003 ) $ ( 1,769 )

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

Amortization of right of use asset

Net gain/loss on disposal of property and equipment

Net gain on disposal of property and equipment

Stock-based compensation

3 unchanged sentences

Accrued expenses

Lease liability

Net cash used in operating activities

( 4,003 ) ( 1,275 )

Cash flows from investing activities:

Asset sale proceeds

Cash paid for purchase of property and equipment

Net cash used in investing activities

Net cash provided by (used in) investing activities

Cash flows from financing activities:

1 unchanged sentence

Net proceeds from the issuance of common stock and warrants

Payments of taxes for net shares settled restricted stock unit issuances

Net cash provided by financing activities

Net decrease in cash, cash equivalents and restricted cash

Net increase (decrease) in cash, cash equivalents and restricted cash

( 4,000 ) 7,896

Cash, cash equivalents and restricted cash at the beginning of period

Cash, cash equivalents and restricted cash at end of period

Supplemental disclosure of cash flow information:

Interest paid

$ 17,031 $ 13,278

See accompanying notes to consolidated financial statements.

19 unchanged sentences

The Company operates as one operating segment and all assets are located in the United States.

Reverse Stock Split

Effective July 5, 2024, the Company completed a 1 -for- 9 reverse stock split of the Company’s outstanding common stock, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.

The reverse stock split did not reduce the number of authorized shares of the Company’s common or preferred stock.

All share and per share amounts have been adjusted to give effect to the reverse stock split.

Use of Estimates

6 unchanged sentences

The Company’s ability to continue to fund its operations is dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, or strategic opportunities, in order to maintain its operations.

This is dependent on a number of factors, including the market demand or liquidity of the Company’s common stock.

This is dependent on a number of factors, including the market demand or liquidity of the Company’s common stock ("Common Stock").

There is no guarantee that debt, additional equity or other funding will be available to the Company on acceptable terms, or at all.

If the Company fails to obtain additional funding when needed, the Company would be forced to scale back or terminate its operations or seek to merge with or to be acquired by another company.

Based on current cash flow projections, the Company believes it has sufficient cash and cash equivalents, including net proceeds from its November 2025 Financing (as defined below), to meet its current planned obligations for at least 12 months from the date these financial statements are issued.

Based on current cash flow projections, the Company believes it has sufficient cash and cash equivalents, including net proceeds from its January 2025 Offerings, July 2025 Financing, and November 2025 Financing, (collectively, "the 2025 Financings"), to meet its current planned obligations for at least 12 months from the date these financial statements are issued.

The Company has limited cash resources, has incurred recurring operating losses and negative cash flows from its operations since its inception and has not yet recognized any product revenues.

These factors have previously raised doubt about the Company’s ability to continue as a going concern.

With the net proceeds from the November 2025 Financing, the Company was able to alleviate such doubt as of the date of the filing of this Quarterly Report on Form 10 -Q.

With the 2025 Financings, the Company was able to alleviate such doubt about its ability to continue as a going concern as of the date the September 30, 2025 financial statements were issued, accordingly, no going-concern disclosures are required for the current period under ASC 205 - 40 as of the date of the filing of this Quarterly Report on Form 10 -Q.

Summary of Significant Accounting Policies

Cash and Cash Equivalents

Cash and cash equivalents include unrestricted cash accounts, money market investments and highly liquid investment instruments with original maturity of three months or less at the date of purchase.

Other than as set forth above, there have been no material changes to the significant accounting policies disclosed in the Company’s 2024 Form 10 -K.

The Company’s significant accounting policies as of March 31, 2026, are consistent with those described in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2025.

There have been no material changes during the current period.

Recent Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023 - 09, “Income Taxes (Topic 740 ):

Improvements to Income Tax Disclosures,” which requires public business entities to disclose additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate for federal, state, and foreign income taxes.

It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items exceeds a specified threshold.

In addition to new disclosures associated with the rate reconciliation, the ASU requires information pertaining to taxes paid (net of refunds received) to be disaggregated for federal, state, and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative threshold.

The ASU also describes items that need to be disaggregated based on their nature, which is determined by reference to the item’s fundamental or essential characteristics, such as the transaction or event that triggered the establishment of the reconciling item and the activity with which the reconciling item is associated.

The ASU eliminates the historic requirement that entities disclose information concerning unrecognized tax benefits having a reasonable possibility of significantly increasing or decreasing in the 12 months following the reporting date.

This ASU is effective for annual periods beginning after December 15, 2024.

Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.

This ASU should be applied on a prospective basis;

however, retrospective application is permitted.

The Company is currently evaluating the impact that ASU 2023 - 09 will have on its consolidated financial statements.

In November 2024, the FASB issued ASU 2024 - 03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosure (Subtopic 220 - 40 ):

7 unchanged sentences

The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions and allows immediate expensing of certain domestic research and experimental expenditures under new Section 174A of the Internal Revenue Code.

The Company does not expect the impact of the OBBBA to be material to its consolidated financial statements.

The Company has not had a material impact from the OBBBA to its consolidated financial statements.

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities are comprised of the following:

September 30,

Accounts payable trade

2 unchanged sentences

Payroll accruals

$ 950 $ 1,340

Collaboration Agreement

10 unchanged sentences

This settled all future obligations to AgonOx.

The Company did not recognize expense with respect to the Clinical Co-Development Agreement during the three and nine months ended September 30, 2025 .

During the three and nine months ended September 30, 2024 , the Company recognized approximately $ 308,000 and $ 414,000 , respectively, of expense with respect to the Clinical Co-Development Agreement.

The Company leases space for various corporate and research purposes.

It is the Company’s policy to apply the provisions of ASC 842 when accounting for arrangements that meet the criteria to be a lease.

The Company leases space for various corporate and research purposes and accounts for lease arrangements in accordance with the provisions of ASC 842, Leases.

The Company calculates the lease liability as the present value of the lease’s cash flows using the interest rate implicit in the lease, if determinable.

2 unchanged sentences

The Company has elected the accounting policy election available under ASC 842 to not record a lease liability for leases with a term of less than one year.

From April 2014 to March 2024, the Company leased space that was utilized as its corporate headquarters and primary laboratory.

The lease expired on March 31, 2024.

On March 1, 2024, the Company commenced a lease for a laboratory facility located at 17 Briden Street, Worcester, Massachusetts.

The lease had an original expiration date of August 31, 2024 and was subsequently extended through February 28, 2025.

The Company continues to lease the space on a month-to-month basis.

Monthly rent is approximately $ 2,600 .

In March 2025, the Company contracted with LifeSciences PA located at 411 Swedeland Road, King of Prussia, PA 19406 for access to full working space for normal hours of operations at a fee of $ 300 per month, which can be cancelled at any time.

Operating lease costs included in operating expense were approximately $ 9,000 and $ 8,000 for the three months ended September 30, 2025 and 2024 , respectively.

Operating lease costs included in operating expense were approximately $ 22,000 and $ 19,000 for the nine months ended September 30, 2025 and 2024 , respectively.

There was no cash paid for the amounts included in the measurement of the operating lease liability on the Company’s condensed consolidated balance sheets and included within changes in the lease liability in the operating activities of the Company’s condensed consolidated statements of cash flows for the Company’s former corporate headquarters for the three months ended September 30, 2025 and 2024 .

Cash paid for the amounts included in the measurement of the operating lease liability on the Company’s condensed consolidated balance sheets and included within changes in the lease liability in the operating activities of the Company’s condensed consolidated statements of cash flows was $ 0 and $ 35,000 for the nine months ended September 30, 2025 and 2024 , respectively.

On March 1, 2024, the Company commenced an operating lease for a laboratory facility located at 17 Briden Street, Worcester, Massachusetts, which expired on February 28, 2026.

The Company currently maintains shared office space at LifeSciences PA located at 411 Swedeland Road, King of Prussia, PA for access to full working space during normal business hours of operations for a monthly fee of $ 300 .

This arrangement is cancellable at any time.

Operating lease costs included in operating expense were approximately $ 900 and $ 8,400 for the three months ended March 31, 2026 and 2025 , respectively.

Stockholders ’ Equity

May 2024 Financing

On May 16, 2024, the Company entered into a purchase agreement (the “ Purchase Agreement ”) with Triton Funds LP (“ Triton ”), pursuant to which the Company agreed to sell, and Triton agreed to purchase, upon the Company’s request in one or more transactions, up to 95,833 shares of Common Stock at a purchase price of $ 6.48 per share (the “ Purchase Price ”), for aggregate gross proceeds of up to $ 621,000 .

The Company recorded expense of approximately $ 100,000 , primarily related to legal fees, in connection with the execution of the Purchase Agreement with Triton.

On July 3, 2024, the Company terminated the Purchase Agreement with Triton effective immediately.

No shares of Common Stock were sold by the Company pursuant to the Purchase Agreement prior to termination.

July 2024 Financing

On July 11, 2024, the Company entered into inducement letter agreements (the “ July 2024 Inducement Letter Agreements ”) with certain holders of certain of the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of Common Stock.

The existing warrants were originally issued in February 2020 through December 2023, having exercise prices between $ 324.00 and $ 9.72 per share.

Pursuant to the July 2024 Inducement Letter Agreements, these warrants were exercised for cash at a reduced exercise of $ 5.45 per share in consideration of the Company’s agreement to issue new unregistered five and one -half year term Series C warrants to purchase up to 583,098 shares of Common Stock at an exercise price of $ 5.45 and new unregistered eighteen month term Series D warrants to purchase up to 507,474 shares of Common Stock at an exercise price of $ 5.45 , both issued and sold at a price of $ 0.125 per warrant share (the “ July 2024 Financing ”).

In addition, the Company issued warrants to H.C.

Wainwright & Co., LLC (the “ Placement Agent ”) to purchase a total of 40,896 shares of Common Stock at an exercise price of $ 6.8125 per share.

The net proceeds to the Company from the July 2024 Financing were approximately $ 2,646,000 , after deducting placement agent fees and offering expenses.

The Company incurred non-cash equity issuance costs of approximately $ 2.4 million for the incremental fair value of the outstanding equity classified warrants and approximately $ 0.2 million for placement agent warrants.

Pursuant to the terms of the July 2024 Inducement Letter Agreements, in the event that the exercise of the existing warrants in the July 2024 Financing would have otherwise caused a holder to exceed the beneficial ownership limitations set forth in the existing warrant, the Company issued the number of shares that would not cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of Common Stock in abeyance.

Accordingly, an aggregate of 328,758 shares of Common Stock were held in abeyance (the “ July 2024 Abeyance Shares ”) with such July 2024 Abeyance Shares evidenced through the holder’s existing warrants and which are deemed to be prepaid.

The July 2024 Abeyance Shares were held until notice was received by the holder that the balance of the shares of Common Stock could be issued in compliance with such beneficial ownership limitations and were exercised pursuant to a notice of exercise from the holder.

Until such time, the Abeyance Shares were evidenced through the holder’s existing warrants and have been included in the Company’s table of outstanding warrants below.

During the year ended December 31, 2024, all of the July 2024 Abeyance Shares were released.

December 19, 2024 Concurrent Registered Direct Offering and Private Placement

On December 19, 2024, the Company entered into a securities purchase agreement (the “ December 19, 2024 Securities Purchase Agreement ”) with certain institutional and accredited investors in connection with a registered direct offering (the “ December 19, 2024 Registered Direct Offering ”) and concurrent private placement (the “ December 19, 2024 Private Placement ” and, together with the December 19, 2024 Registered Direct Offering, the “ December 19, 2024 Offerings ”).

The December 19, 2024 Offerings closed on December 20, 2024.

The net proceeds to the Company from the December 19, 2024 Offerings were approximately $ 900,000 , after deducting placement agent fees and offering expenses.

Pursuant to the December 19, 2024 Securities Purchase Agreement, the Company offered and sold in the December 19, 2024 Registered Direct Offering 437,192 shares of Common Stock at a purchase price of $ 2.635 per share.

In the December 19, 2024 Private Placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase up to 437,192 shares of Common Stock (the “ Series E Warrants ”).

Under the terms of the December 19, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 19, 2024 Registered Direct Offering, an accompanying Series E Warrant was issued to the purchaser thereof.

Each Series E Warrant is exercisable for one share of Common Stock at an exercise price of $ 2.51 per share and will expire on December 20, 2029.

The Series E Warrants were offered and sold at a purchase price of $ 0.125 per Series E Warrant, which purchase price is included in the offering price per share of Common Stock issued in the December 19, 2024 Registered Direct Offering.

December 23, 2024 Concurrent Registered Direct Offering and Private Placement

On December 23, 2024, the Company entered into a securities purchase agreement (the “ December 23, 2024 Securities Purchase Agreement ”) with certain institutional and accredited investors in connection with a registered direct public offering (the “ December 23, 2024 Registered Direct Offering ”) and concurrent private placement (the “ December 23, 2024 Private Placement ” and, together with the December 23, 2024 Registered Direct Offering, the “ December 23, 2024 Offerings ” and, together with the December 19, 2024 Offerings, the “ December 2024 Offerings ”).

The December 23, 2024 Offerings closed on December 24, 2024.

The net proceeds to the Company from the December 23, 2024 Offerings were approximately $ 480,000 , after deducting placement agent fees and offering expenses.

Pursuant to the December 23, 2024 Securities Purchase Agreement, the Company offered and sold in the December 23, 2024 Registered Direct Offering 240,000 shares of Common Stock at a purchase price of $ 2.00 per share.

In the December 23, 2024 Private Placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase up to 240,000 shares of Common Stock (the “ Series F Warrants ”).

Under the terms of the December 23, 2024 Securities Purchase Agreement, for each share of Common Stock issued in the December 23, 2024 Registered Direct Offering, an accompanying Series F Warrant was issued to the purchaser thereof.

Each Series F Warrant is exercisable for one share of Common Stock at an exercise price of $ 2.00 per share and will expire on December 24, 2029.

The Series F Warrants were offered and sold at a purchase price of $ 0.125 per Series F Warrant, which purchase price is included in the offering price per share of Common Stock issued in the December 23, 2024 Registered Direct Offering.

In connection with the December 2024 Offerings, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 50,789 shares of Common Stock (the “ Placement Agent Warrants ”), which represent 7.5 % of the aggregate number of shares of Common Stock sold in the December 19, 2024 Registered Direct Offering and the December 23, 2024 Registered Direct Offering.

The Placement Agent Warrants have substantially the same terms as the Series E Warrants and the Series F Warrants, except that (i) 32,789 of the Placement Agent Warrants have an exercise price equal to $ 3.2938 , or 125 % of the offering price per share of Common Stock sold in the December 19, 2024 Registered Direct Offering, and are exercisable until December 19, 2029, and (ii) 18,000 of the Placement Agent Warrants have an exercise price equal to $ 2.50 , or 125 % of the offering price per share of Common Stock sold in the December 23, 2024 Registered Direct Offering, and are exercisable until December 23, 2029.

January 13, 2025 Concurrent Registered Direct Offering and Private Placement

1 unchanged sentence

The January 13, 2025 Offerings closed on January 14, 2025.

In addition, the Company issued warrants to the Placement Agent to purchase a total of 79,775 shares of Common Stock at an exercise price of $ 3.75 per share.

In addition, the Company issued warrants to the placement agent, H.C.

Wainwright & Co, LLC (“ HCW ”) to purchase a total of 79,775 shares of Common Stock at an exercise price of $ 3.75 per share.

The net proceeds to the Company from the January 13, 2025 Registered Direct Offerings and the January 13, 2025 Private Placement were approximately $ 2.8 million, after deducting fees and estimated offering expenses.

6 unchanged sentences

The January 14, 2025 Offerings closed on January 15, 2025.

In addition, the Company issued warrants to the Placement Agent to purchase a total of 62,500 shares of Common Stock at an exercise price of $ 3.75 per share.

In addition, the Company issued warrants to the placement agent, HCW, to purchase a total of 62,500 shares of Common Stock at an exercise price of $ 3.75 per share.

The net proceeds to the Company from the January 14, 2025 Registered Direct Offering and the January 14, 2025 Private Placement were approximately $ 2.1 million, after deducting fees and estimated offering expenses.

6 unchanged sentences

The January 16, 2025 Offerings closed on January 17, 2025.

In addition, the Company issued warrants to the Placement Agent to purchase a total of 45,750 shares of Common Stock at an exercise price of $ 3.75 per share The net proceeds to the Company from the January 16, 2025 Registered Direct Offering and the January 16, 2025 Private Placement were approximately $ 1.6 million, after deducting fees and estimated offering expenses.

In addition, the Company issued warrants to the placement agent, HCW, to purchase a total of 45,750 shares of Common Stock at an exercise price of $ 3.75 per share The net proceeds to the Company from the January 16, 2025 Registered Direct Offering and the January 16, 2025 Private Placement were approximately $ 1.5 million, after deducting fees and estimated offering expenses.

Pursuant to the January 16, 2025 Securities Purchase Agreement, the Company offered and sold in the January 16, 2025 Registered Direct Offering 610,000 shares of Common Stock at a purchase price of $ 3.00 per share.

3 unchanged sentences

July 2025 Financing

On July 25, 2025, the Company entered into inducement letter agreements (the “ July 2025 Inducement Letter Agreements ”) with certain holders of certain of the Company’s existing warrants to purchase an aggregate of 928,596 shares of the Company’s common stock.

Pursuant to the July 2025 Inducement Letter Agreements, the existing warrants were originally issued in December 2024 and January 2025, having exercise prices between $ 2.00 and $ 3.00 per share.

Warrants to purchase 100,000 shares of Common Stock at the existing exercise price of $ 2.00 per share were exercised at their existing exercise price of $ 2.00 per share, and warrants to purchase 828,596 shares of Common Stock were exercised at a reduced exercise price of $ 2.485 per share.

In consideration for the immediate exercise of such warrants for cash and the payment of an additional $ 0.125 per New Warrant (as defined below), or an aggregate of $ 232,149 for all New Warrants, the Company agreed to issue new unregistered five -year term Series J warrants (the “ Series J Warrants ”) to purchase an aggregate of up to 318,596 shares of common stock at an exercise price of $ 2.485 and new unregistered 24 -month term Series K warrants (the “ Series K Warrants ” and, together with the Series J Warrants, the “ New Warrants ”) to purchase an aggregate of up to 1,538,596 shares of common stock at an exercise price of $ 2.485 (the “ July 2025 Financing ”).

In addition, the Company issued warrants to the placement agent, H.C.

Wainwright & Co., LLC, to purchase up to 69,645 shares of common stock (the “ Placement Agent Warrants ”).

Pursuant to the July 2025 Inducement Letter Agreements, in consideration for the immediate exercise of such warrants for cash and the payment of an additional $ 0.125 per New July 2025 Warrant (as defined below), or an aggregate of $ 232,149 for all New July 2025 Warrants, the Company agreed to issue new unregistered five -year term Series J warrants (the “ Series J Warrants ”) to purchase an aggregate of up to 318,596 shares of Common Stock at an exercise price of $ 2.485 and new unregistered 24 -month term Series K warrants (the “ Series K Warrants ” and, together with the Series J Warrants, the “ New July 2025 Warrants ”) to purchase an aggregate of up to 1,538,596 shares of Common Stock at an exercise price of $ 2.485 (the “ July 2025 Financing ”).

In addition, the Company issued warrants to the placement agent, HCW, to purchase up to 69,645 shares of Common Stock.

7,500 of the placement agent warrants issued have an exercise price of $ 2.8125 per share of Common Stock and a term of five years, 16,395 of the placement agent warrants issued have an exercise price of $ 3.4188 per share of Common Stock and a term of five years, and 45,750 of the placement agent warrants issued have an exercise price of $ 3.4188 per share of Common Stock and a term of twenty-four months.

The net proceeds to the Company from the July 2025 Financing were approximately $ 2.1 million, after deducting placement agent fees and offering expenses.

November 2025 Financing

On November 3, 2025, the Company entered into inducement letter agreements (the “ November 2025 Inducement Letter Agreements ”) with certain holders of the Company’s existing warrants to purchase an aggregate of 5,663,182 shares of Common Stock.

The existing warrants were originally issued in July 2024, December 2024, January 2025 and July 2025, having exercise prices between $ 2.00 and $ 5.45 per share.

Warrants to purchase 60,000 shares of Common Stock were exercised at their existing exercise price of $ 2.00 per share, warrants to purchase 948,596 shares of Common Stock were exercised at their existing exercise price of $ 2.485 per share and warrants to purchase 4,654,586 shares of Common Stock were exercised at a reduced exercise price of $ 2.05 per share.

Pursuant to the November 2025 Inducement Letter Agreements, in consideration for the exercise of such warrants for cash and the payment of an additional $ 0.125 per Series A Warrant (as defined below), or an aggregate of $ 1.4 million for all Series A 2025 Warrants, the Company agreed to issue new unregistered twenty-four month term Series A Warrants (the “ Series A Warrants ”) to purchase an aggregate of up to 11,326,364 shares of Common Stock at an exercise price of $ 2.05 (the “ November 2025 Financing ”).

In addition, the Company issued warrants to the placement agent, HCW, to purchase up to 424,739 shares of Common Stock.

4,500 of the placement agent warrants issued have an exercise price of $ 2.8125 per share of Common Stock and a term of twenty-four months, 349,094 of the placement agent warrants issued have an exercise price of $ 2.875 per share of Common Stock and a term of twenty-four months, and 71,145 of the placement agent warrants issued have an exercise price of $ 3.4188 per share of Common Stock and a term of twenty-four months.

The net proceeds to the Company from the November 2025 Financing were approximately $ 12.1 million, after deducting placement agent fees and offering expenses.

The Company first assesses warrants that are issued by the Company under the FASB ASC Topic 480, “ Distinguishing Liabilities from Equity ” (“ ASC 480 ”) to determine whether the warrants are within the scope of ASC 480.

2 unchanged sentences

Based on the assessment of the warrants issued by the Company under the guidance in ASC 480 and ASC 815, the warrants issued by the Company have been classified within stockholder’s equity.

During the three months ended September 30, 2025 and 2024 , there were 928,596 and 448,292 warrants exercised, respectively.

During the nine months ended September 30, 2025 and 2024 , there were 1,486,028 and 540,112 warrants exercised, respectively.

During the three and nine months ended September 30, 2025 , there were no abeyance shares released and issued.

During the three months ended September 30, 2024 , 231,758 of the July 2024 Abeyance Shares were released and issued and during the nine months ended September 30, 2024, all of the shares held in abeyance in connection with the Company's December 2023 financing transaction were released and issued, and 231,758 of the July 2024 Abeyance Shares were released and issued.

The following table summarizes the Company’s outstanding warrants, all of which are classified as equity instruments, at September 30, 2025 :

During the three months ended March 31, 2026 and 2025 , there were 0 and 537,432 warrants exercised, respectively.

The following table summarizes the Company’s outstanding warrants, all of which are classified as equity instruments, at March 31, 2026 and 2025:

Exercise Price

5 unchanged sentences

( 141,911 ) 10.76 ( 9,659 ) 457.92

Outstanding at September 30,

Outstanding at March 31,

13,386,057 $ 2.86 6,621,118 $ 4.99

3 unchanged sentences

RSUs are generally subject to the satisfaction of certain service requirements.

RSUs granted by the Company to employees generally cliff vest 1 year after the grant date.

Upon vesting, each outstanding RSU will be settled for one share of the Company’s common stock.

RSUs granted by the Company to employees generally cliff vest one year after the grant date.

Upon vesting, each outstanding RSU will be settled for one share of Common Stock.

Employee RSU recipients may elect to net share settle upon vesting, in which case the Company pays the employee’s withholding taxes due upon vesting and withholds a number of shares of equal value.

1 unchanged sentence

The fair value of the RSUs awarded is based upon the Company’s closing stock price at the grant date and is expensed over the requisite service period.

The following table summarizes the activity of the Company’s RSUs for the nine months ended September 30, 2025 :

The following table summarizes the activity of the Company’s RSUs for the three months ended March 31, 2026 :

Unvested units at December 31, 2025

477,700 $ 2.32

( 71,000 ) 2.77

Unvested units at September 30, 2025

Unvested units at March 31, 2026

831,200 $ 2.32

There were 512,800 RSUs granted during the three and nine months ended September 30, 2025 and 71,000 RSUs granted during the three and nine months ended September 30, 2024 .

Stock-based compensation expense related to RSUs was $ 113,000 and $ 52,000 for the three months ended September 30, 2025 and 2024 , respectively.

Stock-based compensation expense related to RSUs was $ 207,000 and $ 99,000 for the nine months ended September 30, 2025 and 2024 , respectively.

The aggregate fair value of awards that vested during the nine months ended September 30, 2025 was $ 164,000 , which represents the market value of the Company's common stock on the date that the RSU vested.

The aggregate fair value of awards that vested during the nine months ended September 30, 2024 was $ 21,000 , which represents the market value of the Company’s common stock on the date that the RSUs vested.

There were 353,500 RSUs granted during the three months ended March 31, 2026 and no RSUs granted during the three months ended March 31, 2025 .

Stock-based compensation expense related to RSUs was $ 318,000 and $ 43,000 for the three months ended March 31, 2026 and 2025 , respectively.

No RSUs vested during the three months ended March 31, 2026 and 2025, respectively.

Stock Options

Stock options are available for issuance under the 2020 Plan.

Stock options granted by the Company to participants generally vest annually over 4 years after the grant date and generally vest over 1 year after the grant date for members of the Board of Directors and expire within ten years of grant.

The Company uses the Black-Scholes option-pricing model to determine the fair value of all its option grants.

The risk-free interest rate used for each grant was based upon the yield on zero -coupon U.S.

Treasury securities with a term similar to the expected life of the related option.

The Company’s expected stock price volatility assumption is based upon the Company’s own implied volatility.

As the Company has limited stock option exercise information, the expected life assumption used for option grants is based upon the simplified method provided for under the FASB ASC Topic 718, “ Compensation — Stock Compensation ”.

The dividend yield assumption is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends.

The Company did not grant any stock options during the three or nine months ended September 30, 2025 or 2024 .

The following table summarizes the activity of the Company’s stock options for the nine months ended September 30, 2025 :

Balance at December 31, 2024

1,126 $ 1,206.29

( 5 ) 133,863.84

Balance at September 30, 2025

1,121 $ 614.60 $ -

Exercisable at September 30, 2025

1,121 $ 614.60 $ -

Stock-based compensation expense related to stock options for the nine months ended September 30, 2025 and 2024 was $ 0 and $ 6,000 , respectively.

The Company did not have any stock-based compensation expense related to stock options for the three months ended September 30, 2025 and 2024 .

Stock options granted by the Company to participants generally vest annually over four years from the grant date and expire ten years from the date of the grant.

All outstanding stock options continue to be accounted for in accordance with ASC 718.

The Company did not grant any stock options during the three months ended March 31, 2026 or 2025 .

As of March 31, 2026, there were 1,115 stock options outstanding.

The Company did not have any stock-based compensation expense related to stock options for the three months ended March 31, 2026 and 2025 .

Compensation Expense Related to Equity Awards

The following table sets forth total stock-based compensation expense for the three and nine months ended September 30, 2025 and 2024 , in thousands:

The following table sets forth total stock-based compensation expense for the three months ended March 31, 2026 and 2025 , in thousands:

Three Months Ended

Nine Months Ended

September 30,

Research and development

$ 30 $ 25 $ 61 $ 14

General and administrative

Total stock-based compensation

$ 113 $ 52 $ 207 $ 99

As of September 30, 2025 , the total unrecognized compensation cost related to non-vested RSUs was approximately $ 1,125,000 .

As of March 31, 2026 , the total unrecognized compensation cost related to non-vested RSUs was approximately $ 754,000 .

This cost is expected to be recognized over a weighted-average period of 0.45 years.

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The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:

September 30,

Stock options

Unvested RSUs

831,200 71,000

13,386,057 6,621,118

14,218,372 6,693,244

Segment Information

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The accounting policies of the single segment are the same as those described in the summary of significant accounting policies.

The CODM assesses performance for the single segment and decides how to allocate resources based on net loss as reported on the condensed consolidated statements of operations as net loss.

The CODM assesses performance for the single segment and decides how to allocate resources based on net loss as reported on the condensed consolidated statements of operations.

The CODM uses net loss to monitor budget versus actual results and to evaluate overall cash burn of the business.

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Three Months Ended

Nine Months Ended

September 30,

Research and development

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Employee expense, lab supplies and overhead

428 281 1,183 1,584

Total research and development

1,181 644 3,141 2,658

General and administrative

1,324 946 3,545 3,055

Total operating expenses

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$ ( 4,003 ) $ ( 1,769 )

$ ( 2,392 ) $ ( 1,524 ) $ ( 6,327 ) $ ( 5,524 )

Subsequent Events

On November 3, 2025, the Company entered into inducement letter agreements (the “ November 2025 Inducement Letter Agreements ”) with certain holders of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 5,663,182 shares of the Company’s common stock.

These warrants were originally issued in July 2024, December 2024, January 2025 and July 2025, having exercise prices between $ 2.00 and $ 5.45 per share.

Warrants to purchase 60,000 shares of common stock were exercised at their existing exercise price of $ 2.00 per share, warrants to purchase 948,596 shares of common stock were exercised at their existing exercise price of $ 2.485 per share and warrants to purchase 4,654,586 shares of common stock were exercised at a reduced exercise price of $ 2.05 per share.

Pursuant to the November 2025 Inducement Letter Agreements, in consideration for the exercise of such warrants for cash and the payment of an additional $ 0.125 per new unregistered warrant, or an aggregate of $ 1.4 million for all new warrants, the Company agreed to issue new unregistered twenty-four month warrants (the “ Series A Warrants ”) to purchase an aggregate of up to 11,326,364 shares of common stock at an exercise price of $ 2.05 (the “November 2025 Financing ”)

The gross proceeds to the Company from the November 2025 Financing are approximately $ 13.4 million, prior to deducting placement agent fees and offering expenses of an anticipated $ 1.3 million.

Pursuant to the terms of the November 2025 Inducement Letter Agreements, in the event that the exercise of the existing warrants in the November 2025 Financing would have otherwise caused a holder to exceed the beneficial ownership limitations set forth in the existing warrant, the Company issued the number of shares that would not cause a holder to exceed such beneficial ownership limitation and agreed to hold such balance of shares of common stock in abeyance.

Accordingly, an aggregate of 1,302,822 shares of common stock were held in abeyance (the “ November 2025 Abeyance Shares ”) with such November 2025 Abeyance Shares evidenced through the holder’s existing warrants and which are deemed to be prepaid.

The November 2025 Abeyance Shares will be held until notice is received by the holder that the balance of the shares of common stock may be issued in compliance with such beneficial ownership limitations and may be exercised pursuant to a notice of exercise from the holder.

Until such time, the November 2025 Abeyance Shares are evidenced through the holder’s existing warrants.

Subsequent to the balance sheet date and through the date of the filing with the SEC of this Quarterly Report on Form 10 -Q, 800,000 of the November 2025 Abeyance Shares were released.

At The Market Offering Agreement

On April 8, 2026, the Company entered into an At the Market Agreement ("Sales Agreement") with HCW pursuant to which the Company may offer and sell shares of Common Stock, having an aggregate price of up to $ 6,360,000 from time to time through HCW, acting as sales agent (the "ATM Program").

The Company is not obligated to sell any shares under the ATM Program and may suspend or terminate the program at any time.

Net proceeds from sales of shares under the ATM Program, after deducting sales commissions and other offering expenses, are intended to fund the development of PH- 762 in an expected Phase 2b/3 clinical trial for cutaneous squamous cell carcinoma, other development activities and for general working capital needs.

Subsequent to March 31, 2026, and through the date of issuance of these financial statements, the Company did not sell any shares of Common Stock under the ATM Program and did not receive any proceeds therefrom.

MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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or MirImmune, LLC.

This management ’ s discussion and analysis of financial condition as of September 30, 2025 and results of operations for the three and nine months ended September 30, 2025 and 2024 should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (the “ SEC ” ) on March 31, 2025 (the “ 2024 Form 10-K ” ).

This management ’ s discussion and analysis of financial condition as of March 31, 2026 and results of operations for the three months ended March 31, 2026 and 2025 should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the “ SEC ” ) on March 5, 2026 (the “ 2025 Form 10-K ” ).

This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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Our actual results and financial condition may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to:

we are dependent on the success of our INTASYL ™ technology, and our product candidates based on this technology, which is unproven and may never lead to approved and marketable products;

we are dependent on the success of our INTASYL TM technology, and our product candidates based on this technology, which is unproven and may never lead to approved and marketable products;

our product candidates are in an early stage of development and we may fail, experience significant delays, never advance in clinical development or not be successful in our efforts to identify or discover additional product candidates, which may materially and adversely impact our business;

disruptions at the FDA, including due to a reduction in the FDA ’ s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business;

the impact of the government shutdown on our business operation;

if we experience delays or difficulties in identifying and enrolling subjects in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary regulatory approvals;

topline data may not accurately reflect or may materially differ from the complete results of a clinical trial;

interim and topline data may not accurately reflect or may materially differ from the complete results of a clinical trial;

we rely upon third parties for the manufacture of the clinical supply for our product candidates;

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future financing may be obtained through, and future development efforts may be paid for by, the issuance of debt or equity, which may have an adverse effect on our stockholders or may otherwise adversely affect our business;

changes in U.S.

and international trade policies may adversely impact our business and operating results;

we may not be able to remain compliant with the continued listing requirements of The Nasdaq Capital Market;

the price of our Common Stock has been and may continue to be volatile.

the price of our Common Stock ("Common Stock") has been and may continue to be volatile.

Therefore, you should not rely on any of these forward-looking statements.

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We are committed to discovering and developing innovative cancer treatments for patients by creating new pathways toward a cancer-free future.

In 2023, the Company implemented a cost rationalization program driven by its transition from discovery research to product development.

This resulted in a decision not to renew the lease for office and laboratory space in Marlborough, Massachusetts, which expired on March 31, 2024.

Beginning in April 2024, we have continued operations as a remote business with a laboratory facility in Worcester, Massachusetts.

Beginning in January 2024, we rationalized discovery research personnel resulting in an overall headcount reduction by greater than 50%.

Expense reductions have been redirected to funding the Phase 1b clinical trial with PH-762.

The Company operates as a remote business under a streamlined cost structure and continues to focus its resources on advancing its clinical development programs.

PH-762 is an INTASYL compound designed to reduce the expression of cell death protein 1 (“ PD-1 ”).

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Decreasing the expression of PD-1 can thereby increase the capacity of T cells, which protect the body from cancer cells and infections, to kill cancer cells.

Our preclinical studies have demonstrated that direct-to-tumor application of PH-762 resulted in potent anti-tumoral effects and have shown that direct-to-tumor treatment with PH-762 inhibits tumor growth in a dose dependent fashion in PD-1 responsive and refractory models.

Our non-clinical studies have demonstrated that direct-to-tumor application of PH-762 resulted in potent anti-tumoral effects and have shown that direct-to-tumor treatment with PH-762 inhibits tumor growth in a dose dependent fashion in PD-1 responsive and refractory models.

Importantly, direct-to-tumor administration of PH-762 resulted in activity against distant untreated tumors, indicative of a systemic anti-tumor response.

We believe these data further support the potential for PH-762 to provide a strong local immune response without the dose immune-related adverse effects seen with systemic antibody therapy.

Phio's ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

Per the trial’s protocol, patients receive four injections of PH-762 at weekly intervals and pathologic response is assessed on day 36 after the initial injection of PH-762.

To date, pathologic results for the fifth and final cohort are as follows:

100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient at Day 36.

To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial.

The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance).

A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance).

Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance).

No patients in the study, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial.

Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort.

Phio may continue to screen and treat additional patients as part of the fifth cohort.

Due to INTASYL’s ease of administration, we have shown that our compounds can easily be incorporated into current Adoptive Cell Therapy (ACT) manufacturing processes.

In ACT, T cells are usually taken from a patient's own blood or tumor tissue, grown in large numbers in a laboratory, and then given back to the patient to help the immune system fight cancer.

By treating T cells with our INTASYL compounds while they are being grown in the laboratory, we believe our INTASYL compounds can improve these immune cells to make them more effective in killing cancer.

Preclinical data generated in collaboration with AgonOx, Inc.

(“ AgonOx ”), a private company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, demonstrated that treating AgonOx’s “double positive” tumor infiltrating lymphocytes (“ DP TIL ”) with PH-762 increased their tumor killing activity by two-fold.

In February 2021, we entered into a clinical co-development collaboration agreement (the “ Clinical Co-Development Agreement ”) with AgonOx to develop a T cell-based therapy using PH-762 and AgonOx’s DP TIL.

Under the Clinical Co-Development Agreement, we had agreed to reimburse AgonOx up to $4 million in expenses incurred to conduct a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced melanoma and other advanced solid tumors.

We were also eligible to receive certain future development milestones and low single-digit sales-based royalty payments from AgonOx’s licensing of its DP TIL technology.

In May 2024, we terminated the Clinical Co-Development Agreement with AgonOx, effective immediately.

Effective as of the date of termination, the Clinical Co-Development Agreement and our and AgonOx’s continuing obligations thereunder were terminated in their entirety.

We are no longer required to provide financial support for the development costs incurred in the Clinical Co-Development Agreement and we are no longer entitled to future development milestones or royalty payments from AgonOx’s licensing of its DP TIL technology.

We paid to AgonOx all payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement.

Pursuant to the terms of the Clinical Co-Development Agreement, each of the Company and AgonOx were responsible for its own costs and expenses incurred in connection with the wind-down of the Phase 1 clinical trial.

We made the remaining payment of $34,320, which primarily related to accrued obligations for patient fees and other miscellaneous costs as of the date of termination to AgonOx on March 21, 2025.

This settled all future obligations to AgonOx.

Prior to the termination of the Clinical Co-Development Agreement with AgonOx, PH-762 treated DP TIL were being evaluated in a Phase 1 clinical trial in the U.S.

with up to 18 patients with advanced melanoma and other advanced solid tumors by AgonOx.

The primary trial objectives were to evaluate the safety and to study the potential for enhanced therapeutic benefit from the administration of PH-762 treated DP TIL.

AgonOx had enrolled three patients.

The first two patients were treated with DP TIL only and a third patient was treated with a combination of DP TIL and PH-762.

Clinical results for the single patient who received a combination of DP TIL and PH-762 showed tumor size reductions of 65%, 100% and 81%, respectively, in three melanoma lesions.

PH-762 was evaluated in a U.S.

multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.

The trial (NCT 06014086) was designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762.

The study was fully enrolled in November 2025 with a total of 22 patients, 20 with cutaneous squamous cell carcinoma, one with melanoma and one with Merkel cell carcinoma.

The clinical phase of the trial is complete, and the final data is currently being analyzed.

While final study data is pending formal analysis, an FDA submission intended to propose and seek guidance for next steps in clinical study design for PH-762 is targeted for the second quarter of 2026.

A total of 22 patients with cutaneous carcinomas completed treatment in the Phase 1b trial and underwent excision of the treated lesional site.

Reported data supports an overall response rate of 65% for squamous cell carcinomas (cSCC).

Among the 20 patients with cSCC, 13 patients were classified as pathologic responders, including 9 patients with complete response (100% clearance), 2 patients with major/near clear response (greater than 90% clearance), and 2 patients with partial response (greater than 50% clearance).

A single patient with metastatic Merkel cell carcinoma had a partial response.

Seven cSCC patients and one melanoma patient had responses of less than 50%, however, none of these patients experienced a progression of the disease.

In the trial, intratumoral injection of PH-762 was well tolerated in all enrolled patients and there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in any patients who received intratumoral PH-762.

PH-762 has been evaluated in patients within five dose-escalating cohorts, increasing drug concentration 20-fold from the first to the final cohort.

Safety data through an extended follow-up period is expected to be reported in the second quarter of 2026.

In July 2025, we entered into a comprehensive drug substance development services agreement with a U.S.

manufacturing company pursuant to which the manufacturer will provide analytical and process development and cGMP manufacture of clinical supplies for Phio's lead development compound, PH-762.

manufacturing company pursuant to which the manufacturer will provide analytical and process development activity, and cGMP manufacture of drug substance to manufacture clinical supplies for our lead development compound, PH-762.

In December 2025, we entered into a development services agreement with a U.S.

laboratory to conduct a nonclinical toxicology study for PH-762, which is required by the FDA prior to commencing a human clinical trial for registration purposes.

In March 2026, we entered into a cGMP drug product manufacturing services agreement with a U.S.

manufacturer for clinical supplies and to satisfy strategic objectives associated with advancement of PH-762.

PH-894 is an INTASYL compound that is designed to silence BRD4, a protein that controls gene expression in both T cells and tumor cells, thereby affecting the immune system as well as the tumor.

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Preclinical studies conducted have demonstrated that PH-894 resulted in a strong, concentration dependent and durable silencing of BRD4 in T cells and in various cancer cells.

Similar to PH-762, preclinical studies have also shown that direct-to-tumor application of PH-894 resulted in potent and statistically significant anti-tumoral effects against distant untreated tumors, indicative of a systemic anti-tumor response.

These preclinical data indicate that PH-894 can reprogram T cells and other cells in the tumor microenvironment to provide enhanced immunotherapeutic activity.

We have completed the IND-enabling studies and are in the process of finalizing the study reports required for an IND submission with PH-894.

Similar to PH-762, nonclinical studies have also shown that direct-to-tumor application of PH-894 resulted in potent and statistically significant anti-tumoral effects against distant untreated tumors, indicative of a systemic anti-tumor response.

These nonclinical data indicate that PH-894 can reprogram T cells and other cells in the tumor microenvironment to provide enhanced immunotherapeutic activity.

We have completed the IND-enabling studies.

As a result of the reprioritization to advance our clinical trial with PH-762 in the U.S., we have elected to defer the IND submission for PH-894.

Synergies With Other Therapies

Preclinical studies with our INTASYL compounds in combination with antibodies resulted in enhanced potency in vivo.

The combination of INTASYL with antibodies may also increase the number of addressable drug targets.

Unlike other antibody combination approaches, INTASYL can target multiple protein drug targets in a specific therapeutic dose, thereby enhancing potency while maintaining a favorable tolerability and safety profile.

We have demonstrated nonclinical activity with INTASYL in adoptive cell therapy ("ACT") applications.

In preclinical studies, INTASYL was shown to enhance the activity of ACT therapies, including with tumor infiltrating lymphocytes and natural killer cells.

As demonstrated in these preclinical studies, INTASYL can be efficiently incorporated into current ACT manufacturing processes.

Patents and Patent Applications

INTASYL compounds have a single-stranded phosphorothioate region, a short duplex region, and contain a variety of nuclease-stabilizing and lipophilic chemical modifications that we believe combine the beneficial properties of both conventional RNAi and antisense technologies.

We protect our proprietary information by means of United States and foreign patents, trademarks, and copyrights.

In addition, we rely upon trade secret protection and contractual arrangements to protect certain of our proprietary information and products.

We have pending patent applications that relate to potential drug targets, compounds we are developing to modulate those targets, methods of making or using those compounds, and proprietary elements of our drug discovery platform.

We have also obtained rights to various patents and patent applications under assignment and/or license agreements with third parties, which require us to pay royalties, milestone payments, or both.

We assess our license agreements on an ongoing basis and may from time to time terminate licenses to technology that we do not intend to employ in our technology platforms, or in our product discovery or development activities.

We actively protect our intellectual property and are prosecuting a number of patents and pending patent applications covering our compounds and technologies.

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Other Markets

International PCT

Our portfolio includes 55 issued patents, 50 of which cover our INTASYL platform, and of those 28 cover immuno-oncology compounds and therapeutic uses.

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The following data summarizes the results of our operations for the periods indicated, in thousands:

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Operating expenses

Operating loss

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Comparison of the Three Months Ended March 31, 2026 and 2025

Operating Expenses

The following table summarizes our total operating expenses, for the periods indicated, in thousands:

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Research and development

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Research and Development Expenses

Research and development expenses consist primarily of personnel expenses, including salaries, benefits and RSU stock compensation expense for research and development personnel, contract research organization (CRO) clinical trial costs, technology licenses and other expenses associated with preclinical and clinical development activities.

Our research and development programs are focused on the development of immuno-oncology therapeutics based on our INTASYL technology.

Since we commenced operations, research and development expenses have been a significant portion of our total operating expenses and are expected to constitute the majority of our spending for the foreseeable future.

Research and development expenses for the three months ended September 30, 2025 increased 83% or $500 thousand as compared with the three months ended September 30, 2024.

This increase in research and development expenses was primarily driven by a $400 thousand increase in clinical trial costs, chemistry, manufacturing and controls (CMC) costs in connection with advancing our PH-762 program and a $100 thousand increase in R&D employee personnel related costs.

Research and development expenses for the nine months ended September 30, 2025 also increased by 18% or $500 thousand as compared with the nine months ended September 30, 2024.

This increase was due to higher $300 thousand increase in R&D clinical and CMC costs in connection with advancing our PH-762 program and $200 thousand increase in R&D employee personnel expenses.

Research and development expenses for the three months ended March 31, 2026 increased 215% or $1.9 million as compared with the three months ended March 31, 2025.

This increase in research and development expenses was primarily driven by a $1.6 million increase in nonclinical and clinical trial costs, chemistry, manufacturing and controls (CMC) costs in connection with advancing our PH-762 program and a $220 thousand increase in R&D employee personnel related costs for salary, bonus and stock compensation expense.

Management believes that research and development expenses will continue to increase as we continue to advance our PH-762 program.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and RSU stock compensation expense for general and administrative personnel, professional fees for legal, audit, tax consulting services, as well as other general corporate expenses.

General and administrative expenses for the three months ended September 30, 2025 increased 40% or $400 thousand as compared with the three months ended September 30, 2024.

The increase in general and administrative expenses was primarily driven by a $200 thousand increase in outsourced professional services related to accounting and legal and $77 thousand increase related to an increase in RSU compensation expense..

General and administrative expenses for the nine months ended September 30, 2025 increased by 16% or $500 thousand as compared with the nine months ended September 30, 2024.

This year-to-date increase in general and administrative expenses relates to $300 thousand increase in outsourced professional fees and $200 thousand additional employee personnel costs including accrued bonus and RSU compensation expense.

General and administrative expenses for the three months ended March 31, 2026 increased 39% or $400 thousand as compared with the three months ended March 31, 2025.

The increase in general and administrative expenses was primarily driven by a $98 thousand increase in bonus expense accrual, $228 thousand increase in stock-based compensation expense, $65 thousand increase in investor outreach and $66 thousand increase in professional fees.

Additionally, there was an $115 thousand increase in finance employee-related costs that is offset by a reduction of $248 thousand for outsourced accounting fees in the first quarter of 2025.

Liquidity and Capital Resources

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Since our inception we have incurred operating losses and expect that we will continue to have negative cash flows from our operations and for the foreseeable future.

As of September 30, 2025, we had cash and cash equivalents of $10,705,000 as compared with $5,382,000 at December 31, 2024.

The gross proceeds to the Company from the November 2025 Financing are approximately $13.4 million, prior to deducting placement agent fees and offering expenses of an anticipated $1.3 million.

The Company expects to raise approximately $12.1 million of which $11.5 million has been received by the Company, with the remainder expected by November 18, 2025.

Based on current cash flow projections, the Company believes it has sufficient cash and cash equivalents, including net proceeds from the November 2025 Financing, to meet our current planned obligations for at least 12 months from the date these financial statements are issued.

As of March 31, 2026, we had cash and cash equivalents of $17 million as compared with $21 million at December 31, 2025.

Based on current cash flow projections, we believe we have sufficient cash and cash equivalents, including net proceeds from our latest financing that occurred during November 2025, to meet our current planned obligations for at least 12 months.

We have limited cash resources, have incurred recurring operating losses and negative cash flows from our operations since our inception and have not yet recognized any product revenues.

These factors have previously raised doubt about the Company's ability to continue as a going concern.

With the November 2025 Financing, combined with the net proceeds from the January 2025 and July 2025 Offerings, we were able to alleviate such doubt as of the date of the filing of this Quarterly Report on Form 10-Q.

To address our liquidity needs and strengthen our financial position, in April 2026, we established an At The Market Agreement ("Sales Agreement") with H.C.

Wainwright & Co., LLC ("HCW") pursuant to which we may offer and sell shares of our Common Stock having an aggregate offering price of up to $6,360,000 from time to time through HCW, acting as sales agent, at prevailing market prices.

No assurance can be given that any Common Stock will be sold under the Sales Agreement, or if such sales occur, no assurance can be given as to the price or number of shares of Common Stock that will be sold, or the dates on which any such sales will take place.

The following table summarizes our cash flows for the periods indicated, in thousands:

Nine Months Ended

September 30,

Three Months Ended

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by (used in) investing activities

Net cash provided by financing activities

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Net Cash Used in Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2025 increased by $159 thousand as compared to the nine months ended September 30, 2024.

Net Cash Used in Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2025 was approximately $12 thousand as compared to the nine months ended September 30, 2024 where net cash used in investing activities was $0.

The increase in net cash used in investing activities was primarily due to computer equipment purchases during the nine months ended September 30, 2025.

Net cash used in operating activities for the three months ended March 31, 2026 increased by $2.7 million as compared to the three months ended March 31, 2025.

This was primarily driven by net loss from operations in the first quarter of 2026 due to increased development spend.

Net Cash Provided by or Used in Investing Activities

Net cash provided by investing activities for the three months ended March 31, 2026 was $3 thousand for an equipment sale.

Net cash used in investing activities was $2 thousand for the purchase of computer equipment for the three months ended March 31, 2025.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was $ 11.2 million as compared to the nine months ended September 30, 2024 where net cash provided by financing activities was $2.6 million.

The increase in net cash provided by financing activities was primarily due to the issuance of common stock and warrants, and the exercise of warrants, both as described in Note 3 of the condensed consolidated financial statements.

There was no cash provided by financing activities for the three months ended March 31, 2026.

The $9.2 million decrease in net cash provided by financing activities as compared to the three months ended March 31, 2025, was primarily due to the issuance of Common Stock and warrants, and the exercise of warrants in the prior year, both as described in Note 3 of the condensed consolidated financial statements.

Contractual Obligations

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Future Funding Requirements

At September 30, 2025, we had cash and cash equivalents of $10.7 million, which includes aggregate net proceeds of approximately $6.7 million and $2.1 million after deducting fees and estimated offering expenses, from our January 2025 and July 2025 Financings, respectively.

As described in our subsequent event disclosure, we expect to receive $12.1 million from our November 2025 Financing, after deducting placement agent fees and offering expenses.

We expect that our cash and cash equivalents will enable us to fund our current operating plan for at least 12 months from the date these financial statements are issued.

Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements.

At March 31, 2026, we had cash and cash equivalents of $17.0 million.

We expect that our cash and cash equivalents will enable us to fund our current operating plan for at least 12 months.

Due to the difficulty and uncertainty associated with the design and implementation of nonclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements.

However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations.

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We also expect to continue to incur significant costs to comply with corporate governance, internal controls and similar requirements associated with operating as a public reporting company.

Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs such as PH-894, clinical trial expenses for PH-762, competing technological and market developments, general and administrative expenses, and the costs of any strategic acquisitions and/or development of complementary business opportunities.

Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs such as PH-894, nonclinical and clinical trial expenses for PH-762, competing technological and market developments, personnel costs, general and administrative expenses, and the costs of any strategic acquisitions and/or development of complementary business opportunities.

The amount of additional capital we will require will be influenced by many factors, including, but not limited to:

the scope, progress, results, and costs of clinical trials of PH-762;

the scope, progress, results, and costs of nonclinical and clinical trials of PH-762;

our expectations regarding the timing and clinical development of PH-762;

whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs, including PH-894;

the costs involved with manufacturing clinical supply of PH-762;

whether and when we are able to enter into strategic arrangements for our product candidates and the nature of those arrangements;

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disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA;

the impact of the government shutdown on our business operations;

and international trade policies;

our views on the availability, timing, and desirability of raising capital.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements